Sepsis Clinical Trial Puts Test Subjects At Risk, Critics Warn

The consumer watchdog group Public Citizen is calling for a clinical trial involving sepsis patients to stopped, indicating that it is placing patients in grave danger. 

Last month, Public Citizen sent a letter (PDF) to the government calling for an end to the Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis trial (CLOVERS). The letter, addressed to the Office for Human Research Protections in the U.S. Department of Health and Human Services, claims that the clinical trial is flawed, resulting in subjects being given risky, unproven treatments without anyone receiving normal treatment for sepsis, which is life-threatening.

The trial is sponsored by the National Institutes of Health, whose own investigators have warned that the trial puts seriously ill patients at risk for little to no return, according to a report published September 24 by the New York Times.

“The design of this disturbing trial is more akin to an experiment that would be conducted on laboratory animals,” Dr. Michael Carome, director of Public Citizen’s Health Research Group, said in a Public Citizen press release. “These human subjects are unwitting guinea pigs in a physiology experiment that will not advance medical care for sepsis and likely will harm many.”

Public Citizen notes that the trials are currently taking place at 16 different institutions, including Cleveland Foundation, Beth Israel Medical Center, Vanderbilt University Medical Center, Stanford University Hospital and others. The trial is designed to include 2,320 subjects and conclude by March 2021.

The problem, according to critics, is that the study does not involve patients getting the usual care for sepsis, so that there is no baseline by which to compare the two treatments that are the subject of the experiment. Without this control group, Public Citizen notes that the researchers will not be able to determine if the experimental treatments are more dangerous for patients, or how they compare to usual treatment.

“Because septic shock is a potentially rapidly lethal clinical syndrome with a high mortality rate, if a new intervention being tested in a clinical trial is harmful, it will likely add to the organ failure and mortality that are part of the natural history of sepsis,” Public Citizen’s letter warns. “However, without an adequate usual-care control group for comparison to the mortality rate that would occur outside of the trial in similar patients managed according to current usual care, it will be impossible to determine, as the trial progresses, whether one or both of the management strategies being studied is harmful compared with usual care.”

Public Citizen says that the study cannot be fixed and should be stopped.

Sepsis occurs when the body is severely affected by an infection, including bacterial, viral, and fungal infections. The infections spread and cause tissues and organs to shut down. Research indicates sepsis infections may cause half of all hospital deaths.

Recently the World Health Organization called sepsis infections a “global priority” because it leads to millions of deaths each year. Implementing the new protocols across the United States and globally could help save thousands of lives every year.